FDA Product Code QJH: Reverse Central Venous Recanalization System
A Reverse Central Venous Recanalization System Is A Prescription Device Intended For Obtaining Central Venous Access To Facilitate Catheter Insertion Into The Central Venous System. Reverse Recanalization Involves The Initiation Of An Access Path From Within The Vein And Then Progressing To The Skin For Patients With Upper Body Venous Occlusions Or Other Conditions That Preclude Central Venous Access By Other Methods.
Leading manufacturers include Merit Medical System, Inc..
FDA 510(k) Cleared Reverse Central Venous Recanalization System Devices (Product Code QJH)
About Product Code QJH - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QJH since 2020, with 1 receiving FDA clearance (average review time: 105 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QJH have taken an average of 30 days to reach a decision - down from 179 days historically, suggesting improved FDA processing for this classification.
QJH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →